Ronald S. Waife, President
While current technologies hold immense promise, Clinical Data Management (CDM) departments have still not realized the performance capabilities of technologies like EDC, eCOA, and the required integrations with other clinical development departments and tools. “Decades back, the new software tools developed for CDM and other areas of clinical research were being programmed and sold in a vacuum, without understanding the needs of the intended customers,” begins Ronald S. Waife, President, Waife & Associates, Inc. (W&A). W&A began in 1993 to addressing this issue, and since then W&A has been providing services that focus on improving the efficiency and innovation in a client’s clinical development operations. The CDM-related services define roles, processes, and responsibilities for EDC, RBM, IxRS, and eCOA and also mentoring of CDM staff with new skills such as vendor oversight management. “Our services are wide-ranging and always reflective of and responsive to the client’s particular business and operational circumstances,” says Waife. The Needham, MA based firm works globally to apply its domain knowledge and working methods equally to clinical operations, clinical development management, safety and pharmacovigilance operations, vendor oversight management, all technology introductions, and other aspects of clinical research.
W&A’s innovative consulting provides pragmatic customer-specific and immediately operational strategies. “Our consulting helps research sponsors and service providers get the maximum benefits out of their current investments,” explains Waife. W&A’s consulting has expanded to all aspects of clinical development including CDM, Clinical Operations, Pharmacovigilance, and Study Management across large and small sponsors, pharmas and biotechs, CROs, software vendors and investors.
“W&A’s interview techniques and contextual observation have proven to be a highly revealing means of discovering inefficiencies and performance obstacles,” notes Waife. Organizational Preparedness is W&A’s trademarked approach to help clients get the correct people, governance, documents, definitions and processes in place, to properly benefit from new software tools or any other vectors of organizational change.
Our services are wide-ranging and always reflective of and responsive to the client’s particular business and operational circumstances
W&A has repeatedly found that success in changing conditions requires a clear and appropriate approach to governance, and a selection of pragmatic, implementable and measurable actions.
“I’ve always been impatient with theories that do not result in practical use, and skeptical about things that sound too good to be true, or are evaluated on the basis of brand and status instead of intrinsic value,” highlights Waife. Reflecting the same thought process, W&A has developed and adapted several proven methodologies to the unique conditions of clinical development. “We believe in practicing the kind of approaches that work in the time-constrained context of clinical research with its highly educated personnel, pressured projects, entrenched processes, multicultural workgroups and widely dispersed functional control,” delineates Waife.
For instance, a sponsor running large global studies, with thousands of patients and hundreds of sites, was experiencing ineffective communication and breach of trust between the contract research organization (CRO), in-house data management, and academic advisors. Additionally, substantial problems resulted due to under-utilization of the EDC software, and disagreements on process and performance. “We provided a layer of data management expertise and executive perspective, to facilitate the sponsor’s re-assertion of control of the study, and in turn considerably improved the overall operational performance and contributed to a successful pivotal trial,” says Waife.
W&A’s future goal is to continue to monitor the industry trends, stay close to their industry contacts, and listen to their concerns, plans and frustrations. “Our purpose is to make their work easier, more efficient, and help them understand the relevancy of new technologies and industry requirements,” concludes Waife.